MAUDE Adverse Event Report: STRYKER SPINE-US REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48511906B
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was discarded.
Event or Problem Description
A company representative reported that the tip of a reflex hybrid revision driver draw rod screw extractor fractured when removing a screw from the plate and the reflex hybrid plate holder is,"coming apart." the procedure was completed successfully with no surgical delay and no adverse consequence to the patient.This report captures the reflex hybrid revision driver draw rod screw extractor.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device associated with this record was not returned.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.A review of complaint history associated with the subject catalog number was performed, and no adverse trends were observed it was reported that the tip of a reflex hybrid revision driver draw rod screw extractor broke off intra-operatively.Per additional correspondence, the tip fractured when trying to remove the screw after the plate was removed from the patient.The plate was removed due to change of plate's size.The reflex hybrid surgical technique was reviewed: ¿the revision driver may also be used to remove bone screws that have been locked to the plate.The revision driver has a narrow tip that helps to bypass the locking ring and engage the bone screw.The draw rod allows for rigid attachment of the screw to the revision driver.Do not pull the screw out with only the inner shaft/draw rod.¿ note: ¿ensure that the tip is fully expanded(draw rod tightened finger-tight) prior to attempting to remove the screw.¿ note: ¿while the revision driver is attached to the screw, pivoting or angulation of the instrument must be avoided, as it can cause bending or breakage of the inner shaft.¿ ¿while rare, intraoperative fracture or breakage of instruments can occur.Instruments which have experienced extensive use or extensive force are more susceptible to fracture depending on the operative precaution, number of procedures, disposal attention.Instruments must be examined for wear or damage prior to surgery and after sterilization.¿ the cause of the reported event cannot be determined as the device was not returned for evaluation.
Event or Problem Description
A company representative reported that the tip of a reflex hybrid revision driver draw rod screw extractor fractured when removing a screw from the plate and the reflex hybrid plate holder is, "coming apart." the procedure was completed successfully with no surgical delay and no adverse consequence to the patient.This report captures the reflex hybrid revision driver draw rod screw extractor.

• Brand Name: REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 13763305
• Report Number: 0009617544-2022-00031
• Device Sequence Number: 19453156
• Product Code: LXH
• UDI-Device Identifier: 07613327276855
• UDI-Public: 07613327276855
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48511906B
• Device Catalogue Number: 48511906B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/15/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown